Forterra Announces Acquisition of Barbour Concrete Company

Expands Forterra’s Reach into Growing Precast Markets

IRVING, Texas, July 01, 2021 (GLOBE NEWSWIRE) — Forterra, Inc. (“Forterra” or “the Company”) (Nasdaq: FRTA), a leading manufacturer of water and drainage infrastructure pipe and precast products in the United States and Eastern Canada, today announced that it has acquired the business of Barbour Concrete Company & Barbour Building Systems (“Barbour”), a manufacturer of precast concrete products used in drainage, stormwater, utility and other infrastructure applications.

Based in Independence, Missouri, Barbour primarily serves the greater Kansas City metropolitan area. For the past 75 years, Barbour has provided high quality products and service to meet customer needs as well as serving as a leader in the National Precast Concrete Association. Forterra expects to continue operating as Barbour Concrete & Barbour Building Systems for the foreseeable future and believes this acquisition will gain it access to new opportunities for growth in the strong and expanding Kansas City infrastructure and residential markets.

“We expect Barbour will accelerate Forterra’s growth in the precast concrete markets and strengthen our position in the growing Kansas City region. This will position us well to continue growing our business in the surrounding area as well, specifically the Greater Omaha market,” said Karl Watson, CEO of Forterra.

“The acquisition of Barbour will benefit our customers as we provide an expanded suite of products and access to technical expertise that will assist in creating tailored solutions. We’re pleased to welcome Barbour to the Forterra team and, given our shared commitment to quality and strong customer service and relationships, we expect a seamless integration,” said Jason Duncan, Forterra Western Region Vice President.

“After 75 years and four generations of innovations, achievements and leadership in the precast industry, it was the vision of Jim Barbour, through his estate plan, to solidify our future through this acquisition by Forterra. With this life-changing event we are grateful and excited to be able to offer new opportunities to our employees, who are our most valuable assets, and expanded resources for manufacturing and service to our customers,” – said Dan Barbour and Amy Burnett on behalf of the Barbour family.

About Forterra

Forterra, Inc. is a leading manufacturer of water and drainage pipe and products in the U.S. and Eastern Canada for a variety of water-related infrastructure applications, including water transmission, distribution, drainage and stormwater systems. Based in Irving, Texas, Forterra’s product breadth and scale help make it a preferred supplier for water-related pipe and products, serving a wide variety of customers, including contractors, distributors and municipalities. For more information on Forterra, visit forterrabp.com.

About Barbour Concrete

Headquartered in Independence, Missouri, Barbour manufacturers and offers precast concrete products used in storm, sanitary, utility and custom applications. For additional information on Barbour visit barbourconcrete.com.

CONTACT:

Charlie Brown
Executive Vice President, Chief Financial Officer
Forterra, Inc.
[email protected]


Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements should not be read as a guarantee of future performance or results and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on historical information available at the time the statements are made and are based on management’s reasonable belief or expectations with respect to future events, and are subject to risks and uncertainties, many of which are beyond the Company’s control, that could cause actual performance or results to differ materially from the belief or expectations expressed in or suggested by the forward-looking statements.

Some of the risks and uncertainties that could cause actual results to differ materially from those expressed in any forward-looking statements include risks and uncertainties relating to the pending acquisition by Quikrete Holdings, Inc.; the impacts of the COVID-19 pandemic; the level of construction activity, particularly in the residential construction and non-residential construction markets; government funding of infrastructure and related construction activities; the highly competitive nature of our industry and our ability to effectively compete; the availability and price of the raw materials we use in our business; the ability to implement our growth strategy; our dependence on key customers and the absence of long-term agreements with these customers; the level of construction activity in Texas; energy costs; disruption at one or more of our manufacturing facilities or in our supply chain; construction project delays and our inventory management; our ability to successfully integrate acquisitions; labor disruptions and other union activity; a tightening of mortgage lending or mortgage financing requirements; compliance with environmental laws and regulations; compliance with health and safety laws and regulations and other laws and regulations to which we and our products are subject to; our dependence on key executives and key management personnel; our ability, or that of the customers with which we work, to retain and attract additional skilled and non-skilled technical or sales personnel; credit and non-payment risks of our customers; warranty and related claims; legal and regulatory claims; the seasonality of our business and its susceptibility to adverse weather; our contract backlog; our ability to maintain sufficient liquidity and ensure adequate financing or guarantees for large projects; delays or outages in our information technology systems and computer networks; security breaches in our information technology systems and other cybersecurity incidents and additional factors discussed in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, for additional information regarding the risks and uncertainties that may cause actual results to differ materially from those expressed in any forward-looking statement.



Kyndryl Unveils New Operating Model And Global Structure

PR Newswire

ARMONK, N.Y., July 1, 2021 /PRNewswire/ — Kyndryl, the independent public company that will be created following the separation of IBM’s (NYSE: IBM) Managed Infrastructure Services business, today announced its global leadership model to bring its mission-critical technical expertise to a broader set of core digital technology environments.

These announcements are important milestones that will prepare Kyndryl for future success – nothing will change with the IBM Global Technology Services business until after responsibility passes to the Kyndryl team.  IBM remains on track to complete the spin-off by the end of the year.

“Kyndryl is meeting customers where they are on their digital transformation journeys, with a lean and focused team that has the critical skills they depend on to succeed,” said Martin Schroeter, Chief Executive Officer of Kyndryl.  “Our country leaders and managing partners will be empowered to work closely with customers, make quick decisions and access the best global talent in the industry.  Their mission will be to place Kyndryl at the heart of progress for our customers.”

Organizing Around Our Customers
Kyndryl will implement a simplified global leadership model for key markets representing more than three-fourths of Kyndryl revenue.

Kyndryl’s newly appointed leaders will include:

  • Tosca Colangeli, President of Kyndryl United Kingdom and Ireland
  • Xerxes Cooper, President of Kyndryl Canada
  • Paolo Degl‘Innocenti, President of Kyndryl Italy
  • Luis Roca Fernandez, President of Kyndryl Spain and Portugal
  • Markus Koerner, President of Kyndryl Germany
  • Matt Milton, President of Kyndryl United States
  • Kerry Purcell, President of Kyndryl Australia and New Zealand
  • Philippe Roncati, President of Kyndryl France
  • Lingraju Sawkar, President of Kyndryl India
  • Takashi Uesaka, President of Kyndryl Japan

The Kyndryl country presidents are seasoned executives who have significant experience in their markets and who have worked with many of the world’s largest enterprises.  These senior leaders will deliver to our customers global best practices and deploy leading technologies and innovations.

In addition Kyndryl announced that Rick Ruiz will become Kyndryl’s Strategic Markets President and will lead Kyndryl’s activities in all other countries.  Ruiz, a veteran IBM sales and technology executive, has served as general manager for IBM’s Global Technology Services business in Europe, Asia Pacific and the Middle East and Africa, and has also led IBM’s Business Continuity and Resiliency Services.

Global Practices
Kyndryl also announced that it will create six global managed services practices and an advisory and implementation services practice in support of our customers, which will pull together managed services, advisory services and implementation. 

“By integrating multiple offerings into these six practices and applying our mission-critical systems capabilities to a broader digital environment, we will be well positioned to support our customers on their digital transformation,” Kyndryl Group President Elly Keinan said.  “These practices will leverage the most experienced talent in our industry to support our customers’ success.”

The six global practices are:

  • Cloud
  • Applications, Data & AI
  • Security & Resiliency
  • Core Enterprise & zCloud
  • Network & Edge
  • Digital Workplace

Kyndryl also announced the Kyndryl Advisory and Implementation services practice, which will include a group of senior business and technology executives who can advise Kyndryl customers on best-in-class digital environments and the adoption and integration of advanced technologies.

The Corporate Team
Kyndryl has assembled a senior leadership team that draws from executive talent across the IT industry as well as in key industry sectors.

“We’re assembling an outstanding team that has experience not only in technology but in being a tech services customer,” Schroeter said.  “This team understands what it means to be consistently focused on a customer-centric model, and how to invest in people and talent to bring that model to life.”

The senior leadership team, in addition to Schroeter, Group President Keinan and Strategic Markets President Ruiz, currently includes:

  • Nelly Akoth, Chief Transformation Officer
  • Michael Bradshaw, Chief Information Officer
  • Maryjo Charbonnier, Chief Human Resources Officer
  • Vineet Khurana, Controller
  • Una Pulizzi, Global Head of Corporate Affairs
  • Edward Sebold, General Counsel
  • Antoine Shagoury, Chief Technology Officer
  • Maria Bartolome Winans, Chief Marketing Officer

Kyndryl will announce more details on its organization in the near future.

“We are fortunate as a 90,000-person ‘start-up’ to have extraordinary global talent, from IBM Fellows and distinguished engineers to experts at service delivery centers, working with deep skills and more than 3,000 patents that help innovate with our customers,” Schroeter said.  “Over time, we’ll be showing all Kyndryls how they contribute to advancing the vital systems that our customers depend on.”

Kyndryl designs, runs and manages the most modern, efficient and reliable technology infrastructure for the world’s most important businesses and organizations, with the industry’s most experienced services experts.  Its previously announced separation is expected to occur by the end of 2021.  For more information, visit www.kyndryl.com

Contact:

IBM

Edward Barbini, 914-494-7925


[email protected]

 

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/kyndryl-unveils-new-operating-model-and-global-structure-301324071.html

SOURCE IBM

MILLER/HOWARD HIGH INCOME EQUITY FUND DECLARES MONTHLY DISTRIBUTIONS

Woodstock, NY, July 01, 2021 (GLOBE NEWSWIRE) — The Board of Trustees of the Miller/Howard High Income Equity Fund (NYSE: HIE) (the “Fund”) declares cash distributions of $0.048 per share for each of July, August, and September 2021.

 

 HIE: CUSIP–600379 101

Declaration Ex-Date Record Payable
July 1, 2021 July 22, 2021 July 23, 2021 July 30, 2021
July 1, 2021 August 23, 2021 August 24, 2021 August 31, 2021
July 1, 2021 September 22, 2021 September 23, 2021 September 30, 2021

 

The Fund’s current indicated distribution rate based on its closing price on the New York Stock Exchange on June 30, 2021 ($10.48) is 5.50%. The current indicated rate based on the Fund’s net asset value per share ($11.10) is 5.19%. The Fund intends to pay monthly distributions to its shareholders.

 

Each quarter, the Board of Trustees reviews the Adviser’s recommended amount of any potential distribution to shareholders. The Board of Trustees will monitor the Fund’s distribution level. The Fund’s distribution rate may be affected by numerous factors, including changes in realized and projected market returns, Fund performance and other factors. There can be no assurance that an unanticipated change in market conditions or other unforeseen factors will not result in a change in the Fund’s distribution rate at a future time. The distribution rate should not be considered the dividend yield or total return on an investment in the Fund.

 

About the Fund

The Fund is managed by Miller/Howard Investments Inc., based in Woodstock, New York. Miller/Howard Investments Inc.’s total firm assets as of March 31, 2021 were approximately $2.8 billion, including $0.3 billion in assets under advisement. Miller/Howard Investments Inc. focuses on income-producing equities, with an emphasis on high-quality stocks with high yield and strong dividend growth, offering investors the opportunity for capital appreciation, current income, and growth of income. The firm has managed portfolios for major institutions and individuals for nearly three decades.

 

For information, call shareholder servicing:

American Stock Transfer

1-800-937-5449



Catherine Johnston, CFA
Miller/Howard Investments, Inc.
8456799166
[email protected]

Take-Two Interactive Software Acquires Dynamixyz

Take-Two Interactive Software Acquires Dynamixyz

Leader in video-based facial animation services to provide cutting-edge, proprietary technology and services exclusively for Company’s publishing labels and development studios

NEW YORK–(BUSINESS WIRE)–
Take-Two Interactive Software, Inc. (NASDAQ:TTWO) today announced that it has acquired privately-held Dynamixyz, a world-class leader in video-based facial animation services. Founded in 2010 in Cesson-Sévigné, France, Dynamixyz owns and operates a suite of leading-edge, proprietary motion capture, facial-analysis, and full 3D processing tools and technology that combines computer graphics, computer vision, and machine learning. Over the past decade, Dynamixyz has been a valued partner of the entertainment industry, including Take-Two’s wholly-owned labels, Rockstar Games and 2K, and has worked on such acclaimed projects as Red Dead Redemption 2 and NBA 2K21, the animated series Love, Death & Robots, and movies, including Avengers: Endgame. Financial details of the acquisition were not disclosed.

Take-Two’s acquisition of Dynamixyz is the Company’s latest strategic initiative to invest further in its internal development capabilities and to continue its goal to be the most creative, innovative, and efficient entertainment company. Dynamixyz is led by Gaspard Breton, CEO, PhD, Nicolas Stoiber, CTO, PhD, and Olivier Aubault, Managing Director, PhD, and is comprised of a team of more than 15 professionals, with more than 40 combined years of related R&D acumen and expertise. Dynamixyz will operate as a division of Take-Two and work exclusively with the Company’s publishing labels and studios. Mr. Breton will continue to oversee Dynamixyz and report to Scott Belmont, Executive Vice President and Chief Information Officer for Take-Two Interactive Software.

“Dynamixyz’s revolutionary facial analysis technology and services is a highly complementary and strategic addition to Take-Two’s world-class publishing and development structure,” said Michael Worosz, Executive Vice President and Head of Strategy and Independent Publishing for Take-Two. “Gaspard and the visionary team at Dynamixyz have a well-earned reputation for providing the widest and smartest range of facial motion capture solutions to the entertainment industry, and their work has captivated millions of people around the world from the box office to the living room. We’re thrilled to have them join our team, incorporate their proprietary technologies and creative wonder into our future offerings, and to continue to evolve their capabilities and solutions.”

“We’re very excited to join the Take-Two family and become an exclusive partner to their immensely talented studios and teams around the world,” added Gaspard Breton, CEO, PhD of Dynamixyz. “Having worked with Rockstar Games and 2K, we know firsthand Take-Two’s commitment to creative excellence and welcome the opportunity to leverage our tools and technology to help them to achieve that goal and to captivate and engage audiences further.”

Willkie Farr & Gallagher, LLP served as legal counsel to Take-Two. Inflexion Points Technology Partners and Didier & Levy served as financial and legal advisors, respectively, to Dynamixyz.

About Dynamixyz

Founded in 2010, Dynamixyz is a team of PhDs who specialize in computer vision, and in particular, the challenges of capturing the nuances of human faces and expressions. Dynamixyz developed the first software that could provide the same extremely high-end animation tools to a wide array of customers, but previously available to a few studios. The Company now stands as a leading provider in the entertainment industry offering the widest range of marker-less facial motion capture solutions to the market. Dynamixyz technology has been used by major AAA video games and world-acclaimed visual effects and virtual reality applications looking to boost productivity while maintaining a high level of quality in a content pipeline.

About Take-Two Interactive Software

Headquartered in New York City, Take-Two Interactive Software, Inc. is a leading developer, publisher, and marketer of interactive entertainment for consumers around the globe. We develop and publish products principally through Rockstar Games, 2K, Private Division, Social Point, Playdots, and Nordeus. Our products are designed for console systems and personal computers, including smartphones and tablets, and are delivered through physical retail, digital download, online platforms, and cloud streaming services. The Company’s common stock is publicly traded on NASDAQ under the symbol TTWO. For more corporate and product information please visit our website at http://www.take2games.com.

All trademarks and copyrights contained herein are the property of their respective holders.

Cautionary Note Regarding Forward-Looking Statements

The statements contained herein which are not historical facts are considered forward-looking statements under federal securities laws and may be identified by words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “plans,” “potential,” “predicts,” “projects,” “seeks,” “should,” “will,” or words of similar meaning and include, but are not limited to, statements regarding the outlook for the Company’s future business and financial performance. Such forward-looking statements are based on the current beliefs of our management as well as assumptions made by and information currently available to them, which are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Actual outcomes and results may vary materially from these forward-looking statements based on a variety of risks and uncertainties including: the uncertainty of the impact of the COVID-19 pandemic and measures taken in response thereto; the effect that measures taken to mitigate the COVID-19 pandemic have on our operations, including our ability to timely deliver our titles and other products, and on the operations of our counterparties, including retailers and distributors; the effects of the COVID-19 pandemic on both consumer demand and the discretionary spending patterns of our customers as the situation with the pandemic continues to evolve; our ability to successfully integrate Dynamixyz’s operations and employees; the risks of conducting business internationally; the impact of reductions in interest rates by the Federal Reserve and other central banks, including on our short-term investment portfolio; the impact of potential inflation; volatility in foreign currency exchange rates; our dependence on key management and product development personnel; our dependence on our NBA 2K and Grand Theft Auto products and our ability to develop other hit titles; our ability to leverage opportunities on PlayStation®5 and Xbox Series X|S; the timely release and significant market acceptance of our games; the ability to maintain acceptable pricing levels on our games; and risks associated with international operations.

Other important factors and information are contained in the Company’s most recent Annual Report on Form 10-K, including the risks summarized in the section entitled “Risk Factors,” the Company’s most recent Quarterly Report on Form 10-Q, and the Company’s other periodic filings with the SEC, which can be accessed at www.take2games.com. All forward-looking statements are qualified by these cautionary statements and apply only as of the date they are made. The Company undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

(Investor Relations)

Nicole Shevins

Senior Vice President

Investor Relations & Corporate Communications

Take-Two Interactive Software, Inc.

(646) 536-3005

[email protected]

(Corporate Press)

Alan Lewis

Vice President

Corporate Communications & Public Affairs

Take-Two Interactive Software, Inc.

(646) 536-2983

[email protected]

KEYWORDS: United States North America New York

INDUSTRY KEYWORDS: Software Technology Consumer Electronics

MEDIA:

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Veracyte Announces Two Pre-Eminent Physician Appointments, Further Strengthening Medical Team

Veracyte Announces Two Pre-Eminent Physician Appointments, Further Strengthening Medical Team

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Veracyte (Nasdaq: VCYT), a global genomic diagnostics company, today announced key appointments that expand and further strengthen the company’s medical team. William A. Bulman, M.D. and Paul Kelly Marcom, M.D, have joined the company as medical director for Lung Cancer and medical director for Breast Cancer, respectively. Both physician executives report to Richard T. Kloos, M.D., Veracyte’s executive medical director.

“We couldn’t be more excited for Dr. Bulman and Dr. Marcom, two well-respected physicians with exceptional experience and credentials in their respective fields, to be part of the Veracyte team,” said Giulia C. Kennedy, Ph.D., Veracyte’s chief scientific officer and chief medical officer. “Their appointments demonstrate our sincere commitment to building a world-class medical team to support our growing menu of advanced genomic tests that address unmet needs throughout the patient journey. Their expertise will be especially critical as we prepare to launch new products and make these products broadly available to patients, including in global markets.”

Dr. Bulman most recently served as associate professor of Medicine at Columbia University and the director of Interventional Bronchoscopy at New York Presbyterian Hospital. He has worked in pulmonology for 15 years, with clinical interests in interventional bronchoscopy and advanced diagnostic bronchoscopy, chronic obstructive pulmonary disease, and the pulmonary complications of lung cancer. Dr. Bulman also served as course director for the Pulmonary Medicine Section of the first-year curriculum at Columbia University Vagelos College of Physicians and Surgeons, director of the medical school’s Scholarly Projects Program, medical director of the High-Risk Lung Nodule Assessment Center, and the medical director of Columbia Pulmonary Associates, a private practice group.

He has been a research investigator in multiple clinical trials involving bronchoscopic treatments and lung imaging. These included the AEGIS trials, which were used to develop and validate Veracyte’s Percepta Genomic Sequencing Classifier, as well as the company’s Percepta Nasal Swab test for improved early lung cancer detection.

Dr. Bulman graduated from the University of Pennsylvania School of Medicine and completed internships in both surgery and medicine before residency training in Internal Medicine. He served as a chief resident in Medicine and later completed fellowship training in Pulmonary and Critical Care Medicine at Columbia.

Dr. Marcom has over 30 years of experience in oncology, mostly dedicated to treating breast cancer. He joins Veracyte from Duke University Medical Center, where he was disease group leader for the Duke Cancer Institute’s multidisciplinary Breast Cancer Disease Group and a tenured professor of Medicine. Dr. Marcom has conducted extensive research and published over 30 studies on the genetic aspects of breast cancer, including both inherited genetic factors and genomic changes in tumors. He served as a member of the National Comprehensive Cancer Network (NCCN) EHR Oncology Advisory Group and Breast Cancer Panel, and was among the authors of the 2020 NCCN Clinical Practical Guidelines in Oncology for Breast Cancer.

Dr. Marcom has also been awarded nearly 30 grants from organizations such as the Department of Defense, the National Institutes of Health, Mayo Clinic, Novartis Pharmaceuticals Corporation, Innocrin Pharmaceutical, Genentech, Johns Hopkins University, and Celldex Therapeutics, among others, for projects investigating the genetic aspects of breast cancer for detection and prevention, understanding what leads to cancer heterogeneity, and applying this understanding to guide treatment. He graduated from Baylor College of Medicine in 1989 and completed his residency and fellowship at Duke University Medical Center for hematology-oncology and medicine.

About Veracyte

Veracyte (Nasdaq: VCYT) is a global genomic diagnostics company that improves patient care by providing answers to clinical questions, informing diagnosis and treatment decisions throughout the patient journey in cancer and other diseases. The company’s growing menu of genomic tests leverage advances in genomic science and technology, enabling patients to avoid risky, costly diagnostic procedures and quicken time to appropriate treatment. The company’s tests in lung cancer, prostate cancer, breast cancer, thyroid cancer, bladder cancer and idiopathic pulmonary fibrosis are available to patients and its lymphoma subtyping and renal cancer tests are in development. With Veracyte’s exclusive global license to a best-in-class diagnostics instrument platform, the company is positioned to deliver its tests to patients worldwide. Veracyte is based in South San Francisco, California. For more information, please visit www.veracyte.com and follow the company on Twitter (@veracyte).

Veracyte, the Veracyte logo, Decipher, Decipher GRID, Afirma, Percepta, Envisia, Prosigna, Lymphmark, “Know by Design” and “More about You” are registered trademarks of Veracyte, Inc. and its affiliates in the U.S. and selected countries. nCounter is the registered trademark of NanoString Technologies, Inc. in the U.S. and selected countries and used by Veracyte under license.

Investor and Media Contact:

Tracy Morris

Vice President of Corporate Communications

& Investor Relations

650-380-4413

[email protected]

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Biotechnology Health Genetics Pharmaceutical Oncology

MEDIA:

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ICON acquisition creates world-leading healthcare intelligence and clinical research organisation

ICON acquisition creates world-leading healthcare intelligence and clinical research organisation

DUBLIN–(BUSINESS WIRE)–ICON plc, (NASDAQ: ICLR)(“ICON”) today announced the completion of its acquisition of PRA Health Sciences. The combined company will retain the name ICON and will bring together 38,000 employees across 47 countries, creating the world’s most advanced healthcare intelligence and clinical research organisation.

The combined company will leverage its enhanced operations to transform clinical trials and accelerate biopharma customers’ commercial success through the development of much needed medicines and medical devices. The new ICON will have a renewed focus on leveraging data, applying technology and accessing diverse patient populations to speed up drug development.

Transaction close details

Upon completion of the acquisition, pursuant to the terms of the merger agreement, PRA became a wholly owned subsidiary of ICON plc. Under the terms of the merger, PRA shareholders received per share $80 in cash and 0.4125 shares of ICON stock. The trading of PRA common stock on NASDAQ was suspended prior to market open on July 1, 2021.

About ICON plc

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. We develop new innovations, drive emerging therapies forward and improve patient lives. With headquarters in Dublin, Ireland, ICON will operate from 163 locations in 47 countries and have approximately 38,000 employees as of July 1, 2021.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements. These statements are based on management’s current expectations and information currently available, including current economic and industry conditions. These statements are not guarantees of future performance or actual results, and actual results, developments and business decisions may differ from those stated in this press release. The forward-looking statements are subject to future events, risks, uncertainties and other factors that could cause actual results to differ materially from those projected in the statements, including, but not limited to, the ability to enter into new contracts, maintain client relationships, manage the opening of new offices and offering of new services, the integration of new business mergers and acquisitions, the impact of COVID-19 on our business, as well as other economic and global market conditions and other risks and uncertainties detailed from time to time in SEC reports filed by ICON, all of which are difficult to predict and some of which are beyond our control. For these reasons, you should not place undue reliance on these forward-looking statements when making investment decisions. The word “expected” and variations of such words and similar expressions are intended to identify forward-looking statements. Forward-looking statements are only as of the date they are made and we do not undertake any obligation to update publicly any forward-looking statement, either as a result of new information, future events or otherwise. More information about the risks and uncertainties relating to these forward-looking statements may be found in SEC reports filed by ICON, including its Form 20-F, F-1, F-4, S-8 and F-3, which are available on the SEC’s website at http://www.sec.gov.

ICON/ICLR-F

Investor enquiries:

Brendan Brennan, CFO

+35312912000

[email protected]

Jonathan Curtain, VP, Corporate Finance & Investor Relations

+35312912000

[email protected]

Media enquiries:

Weber Shandwick (PR adviser)

Lisa Henry (GMT timezone)

+447785 458203

[email protected]

KEYWORDS: Ireland Europe

INDUSTRY KEYWORDS: Research Banking General Health Professional Services Pharmaceutical Medical Devices Clinical Trials Science Biotechnology Finance Other Science Health

MEDIA:

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Weber Shandwick & Clients Earn 36 Lions across 14 Categories at 2021 Cannes Lions International Festival of Creativity

– Agency credited on Titanium Lion, two Grand Prix winners, seven Gold Lions –

PR Newswire

NEW YORK, July 1, 2021 /PRNewswire/ — Weber Shandwick, one of the world’s leading global communications and marketing services firms, was awarded 36 Lions at the 2021 Cannes Lions International Festival of Creativity in partnership with its clients, including one Titanium Lion, two Grand Prix, seven Gold Lions, nine Silver Lions and 17 Bronze Lions. The agency was the most awarded PR agency this year, with wins across 14 total categories: Health & Wellness, Outdoor, Creative Strategy, Direct, PR, Social & Influencer, Media, Film Craft, Entertainment, Entertainment for Sport, Creative Business Transformation, Brand Experience & Activation, Sustainable Development Goals and Titanium. Overall, the agency was credited on 72 shortlists, including six as idea agency. This year’s wins bring Weber Shandwick’s cumulative total to over 135 Cannes Lions.

Michelob ULTRA’s Contract for Change, led by FCB Chicago with 3PM Agency/Weber Shandwick leading PR, earned a coveted Titanium Lion, which recognizes provocative, breakthrough ideas that point to a new direction in the industry. The campaign offered help to farmers across Idaho, and later the U.S., who wanted to make the voluntary transition to growing organic crops as they face the financial burden and risk of the three-year certification process. Contract for Change was one of two Grand Prix-winning campaigns Weber Shandwick celebrated, winning a Grand Prix in PR in addition to a Gold and Silver Lion in Creative Business Transformation, a Gold Lion and Silver Lion in Direct, a Gold Lion in PR, a Bronze Lion in Creative Strategy and a Bronze Lion in Sustainable Development Goals.

The Bread Exam, led by McCann Paris with Spinneys and the Lebanese Breast Cancer Foundation, was also awarded a Grand Prix for PR, with Weber Shandwick credited as PR agency. The campaign broke through cultural taboos to teach women living in traditional communities in the Middle East to detect early signs of breast cancer. The Bread Exam earned a Gold Lion and Silver Lion in Health & Wellness, a Gold Lion and  Bronze Lion in Media, a Gold Lion and Bronze Lion in PR, a Silver Lion and Bronze Lion in Brand Experience & Activation and a Silver Lion in Social & Influencer.

Weber Shandwick earned an additional Gold Lion, nine Silver Lions and 17 Bronze Lions with clients for the following campaigns:

  • Seven Lions for Michelob ULTRA Courtside for Michelob ULTRA: Media (Gold and Bronze Lions), Brand Experience & Activation (Silver and Bronze Lions), Direct (Bronze Lion), Entertainment (Bronze Lion) and Entertainment for Sport (Bronze Lion) with FCB New York and 3PM Agency/Weber Shandwick
  • Five Lions for The OREO Doomsday Vault for OREO: Brand Experience & Activation (Silver and Bronze Lions), Outdoor (Silver Lion), Direct (Bronze Lion) and Social & Influencer (Bronze Lion) with the community and 360i
  • Two Lions for H for Handwashing for Unilever’s Lifebuoy: Health & Wellness (Bronze Lion) and Media (Bronze Lion) with MullenLowe Lintas Group, MullenLowe Singapore and MullenLowe salt
  • One Lion for Not All Heroes Wear Capes for Bud Light: Entertainment for Sport (Silver Lion) with draftLine and Wieden+Kennedy New York
  • One Lion for We Got You, Baby for Kimberly-Clark Huggies: Film Craft (Bronze Lion) with Droga5, Mindshare and VMLY&R

“In this massively challenging time, our industry and our firm proved to be central to business and society as a whole, expertly weaving ideas into culture to solve complex and often urgent problems for businesses and for society,” said Gail Heimann, CEO, Weber Shandwick. “This centrality as well as the multi-dimensionality of PR is evident in the breadth of categories in which our work was recognized. I’m extraordinarily proud of this recognition, and of the inspiring and impactful work  we’ve produced on behalf of our clients around the world.”

Weber Shandwick Executives Participate across Three Juries

Heimann presided over the 2020/2021 PR Lions jury, evaluating work that spanned an unprecedented period of 18 months. A jury veteran of the Festival, she also served on the 2020/2021 Young Lions PR jury, the 2018 Titanium jury and on the inaugural Glass Lions jury in 2015, and was previously jury president of the PR Lions in 2012.

Additionally, four Weber Shandwick executives joined as jurors across categories this year: Charlotte Witte, executive vice president of brand transformation, served on the Creative Business Transformation jury; Hafida Abahai, CEO, Weber Shandwick Netherlands, and Vanessa Ho Nikolovski, chief client & growth officer in APAC, served as shortlist jury members in the PR category. Ciro Sarmiento, chief creative officer, Weber Shandwick New York, served on the Young Lions Print jury.

The Young Lions PR Competition gives young talent an opportunity compete against peers from around the world. This year, Weber Shandwick Associate Creative Director Louisa Hager and Art Director Andrea Corasanti represented the U.S. in the competition, earning second place honors.

About Weber Shandwick
Weber Shandwick is a leading global communications network that delivers next-generation solutions to brands, businesses and organizations in major markets around the world. Led by world-class strategic and creative thinkers and activators, we have won some of the most prestigious awards in the industry. Weber Shandwick was named to Ad Age’s Agency A-List in 2020 and Best Places to Work in 2019. Weber Shandwick was also honored as PRovoke’s Global Agency of the Decade in 2020 and PRWeek’s Global Agency of the Year in 2015, 2016, 2017 and 2018. The firm has earned more than 135 Lions at the Cannes Lions International Festival of Creativity. Data-led, with earned ideas at the core, the agency deploys leading and emerging technologies to inform strategy, develop critical insights and heighten impact across sectors and specialty areas, including brand and B2B marketing, healthcare marketing, change management, employee engagement, corporate reputation, crisis management, data and analytics, technology, public affairs, social impact and financial communications. Weber Shandwick is part of the Interpublic Group (NYSE: IPG). For more information, visit http://www.webershandwick.com

Contact: Jill Tannenbaum
Company: Weber Shandwick          
Phone: 212-546-7815
Email: [email protected]

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SOURCE Weber Shandwick

Morningstar Risk Ecosystem Launches Across 7 Million Portfolios to Help Advisors Put Investors’ Best Interests at the Core of Investment Advice

PR Newswire

Morningstar Portfolio Risk Score and Risk Comfort Range, new components of the Morningstar Risk Ecosystem, debut as part of creating an investor-centric risk measurement approach for financial advisors seeking to provide more personalized investment advice, meet evolving regulatory standards, and build better businesses

CHICAGO, July 1, 2021 /PRNewswire/ — Morningstar, Inc. (Nasdaq: MORN), a leading provider of independent investment research, today announced the launch of Morningstar Portfolio Risk Score and Risk Comfort Range, new risk measurement tools in the Morningstar Risk Ecosystem, an evidence-based, transparent and independent set of methodologies to provide a more rigorous and manageable client profiling and investment planning process for firms and their advisors.

The launch of the Morningstar Risk Ecosystem, including its new Morningstar Portfolio Risk Score and Risk Comfort Range, marks a new approach to risk measurement and analysis that aligns Morningstar methodologies for scoring portfolio risk and assessing a client’s risk profile and tolerance. Morningstar Portfolio Risk Score will become available next week in Morningstar® Advisor WorkstationSM for advisors in Canada and the U.S. Morningstar Portfolio Risk Score and Risk Comfort Range are both available to third-party platforms now through Morningstar® Enterprise Components, and they will roll out across Morningstar’s flagship platforms through the remainder of 2021. 

In a white paper published today, “Measurement of Client Risk Tolerance: How Improving Methodology Could Offer Advisors a Significant Competitive Advantage,” Morningstar Director of Financial Planning Methodology Shawn Brayman and Director of Product Management Jason Stipp explain the importance of matching clients to compatible portfolios. A 2015 paper by Browning and Finke found 57 percent of U.S. households actively reduced their stock holdings between 2006 and 2008 amid the housing and credit crisis. This effectively locked in losses for some investors and kept them from potential benefits of staying in the stock market for the subsequent rebound.

“Many investors lack access to sound financial planning services, and many advisors use tools that check the box for compliance but may not reliably assess an investor’s risk tolerance and align it to appropriately risky portfolios,” Brayman said. “The Morningstar Risk Ecosystem addresses this with robust, transparent methodologies and simple illustrations, ultimately helping them make more informed, long-term investment decisions.”

Morningstar Portfolio Risk Score measures a portfolio’s level of risk compared with Morningstar’s Target Allocation Index family and can be applied to client portfolios, model portfolios, proposed portfolios, or individual managed investments. In support of its existing subscriber clients, Morningstar has made the Morningstar Portfolio Risk Score available across 7.1 million client portfolios in Morningstar Advisor Workstation, enabling advisors to have deeper conversations with clients and build more targeted financial plans.

Morningstar’s Risk Comfort Range is a methodology to align client expectations about the risk exposure of their portfolios based on their risk profile and investment objectives to an appropriate range of Morningstar Portfolio Risk Scores. This can help the advisor demonstrate compatibility between the investor’s needs and risk tolerance and the recommended investment products or portfolio. Each subsequent enhancement to the Morningstar Risk Ecosystem through 2021 will build on Morningstar’s objective to empower investors and enable advisors to easily document and show clients how their own risk tolerance and comfort measures up against mutual funds, ETFs, or their own portfolio.

“Traditional risk profiling is typically inadequate and does not meet the true needs of investors or advisors serving them. The industry has, for too long, focused on measuring only the risk of investments within a portfolio, resulting in a commoditization of investment advice,” said Jeff Schwantz, head of client advisor experience for Morningstar. “We are putting the priority back on the investor and unlocking an advisor’s ability to see both investor risk and investment risk in one clear view. The result of these integrations will be a new way to measure and understand investment risk, develop truly personalized portfolios and confidently address new and upcoming regulatory standards.”

The methodologies introduced in the Morningstar Risk Ecosystem result from the integration of PlanPlus Global, which Morningstar acquired in 2020, with Morningstar’s financial planning solutions. The foundation of the risk tolerance questionnaire is built on the world’s most academically validated psychometric risk tolerance assessment to give advisors confidence in delivering defensible advice to clients. More than 1.5 million risk tolerance tests have been completed for over 10,000 advisors in 35 countries since 1998.

For more information on the Morningstar Risk Ecosystem, visit https://www.morningstar.com/products/risk.

About Morningstar, Inc. 
Morningstar, Inc. is a leading provider of independent investment research in North America, Europe, Australia, and Asia. The Company offers an extensive line of products and services for individual investors, financial advisors, asset managers and owners, retirement plan providers and sponsors, and institutional investors in the debt and private capital markets. Morningstar provides data and research insights on a wide range of investment offerings, including managed investment products, publicly listed companies, private capital markets, debt securities, and real-time global market data. Morningstar also offers investment management services through its investment advisory subsidiaries, with approximately $244 billion in assets under advisement and management as of March 31, 2021. The Company has operations in 29 countries. For more information, visit www.morningstar.com/company. Follow Morningstar on Twitter @MorningstarInc. 

The sole purpose of the Morningstar Portfolio Risk Score and Risk Comfort Range is to assist investors in determining their general attitudes towards investment risk and to help assess a financial product’s suitability given an investor’s risk tolerance. These tools do not consider all factors necessary in making an investment decision and should not be used as the sole basis for investment decisions. In no way should these tools be viewed as investment advice or establishing any kind of advisory relationship with Morningstar. Morningstar does not endorse and/or recommend any specific financial product that may be used in conjunction with the Morningstar Risk Ecosystem.

MORN-P

CONTACT: Stephanie Lerdall, [email protected]

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SOURCE Morningstar, Inc.

Calvin Klein Fragrances Announces the Global Debut of the Advertising Campaign for Calvin Klein Defy a New Men’s Fragrance

Calvin Klein Fragrances Announces the Global Debut of the Advertising Campaign for Calvin Klein Defy a New Men’s Fragrance

NEW YORK–(BUSINESS WIRE)–
Calvin Klein, Inc., a wholly owned subsidiary of PVH Corp. [NYSE: PVH], and Calvin Klein Fragrances, a division of Coty Inc. [NYSE: COTY], today revealed the worldwide global advertising campaign for Calvin Klein Defy, a new men’s fragrance featuring award-winning actor Richard Madden as the face of this new chapter within the Calvin Klein fragrance portfolio. The fragrance and campaign embrace a journey of defiance while exploring authentic truths and the contrasts within.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210701005525/en/

Calvin Klein Defy (Photo: Business Wire)

Calvin Klein Defy (Photo: Business Wire)

The campaign features Madden in a series of vulnerable, self-reflecting and authentic moments that culminate into a courageous leap of faith, a symbolic metaphor for personal defiance and daring to take risks. The accompanying still visual translates the powerful essence of the campaign featuring Madden seated on a rooftop with a rebellious stare in iconic Calvin Klein jeans and a timeless Calvin Klein white t-shirt. The advertising campaign will be featured globally and supported by digital, social, print and TV.

“It’s been an exciting opportunity to partner with Calvin Klein on this new launch for Calvin Klein Fragrances,” said Madden. “Making the Calvin Klein Defy campaign was an amazing experience; I’m excited about this partnership and our work together.”

The Calvin Klein Defy fragrance features a daring contrast of invigorating freshness and powerful woods. Crafted by Anne Flipo, Master Perfumer, and Senior Perfumers Pascal Gaurin and Loc Dong of IFF, the fragrance defies expectations and evokes the ethos of the campaign opening with an addictive blend of citrus highlighted by crisp Bergamot and fresh Lavender Absolute. The heart of the fragrance and star ingredient, Vetiver Oil, is responsibly sourced from Haiti, and provides a vibrant earthiness and irresistible rugged texture that compliments a rich and alluring base of Amber notes.

The masculine and woody fresh scent is captured in a modern and minimalist glass bottle carved with curved rounded edges and sharp linear lines, representing the duality of vulnerability and courage on the path to defiance. The cap and carton pay homage to Calvin Klein jeans with a matte textured blue denim inspired embossed finish and striking silver branding.

Joanne Bletz, Senior Vice President Global for Calvin Klein Fragrances at Coty said, “We are hugely excited by the launch of Calvin Klein Defy. The creation of this new men’s fragrance, starring the award-winning actor Richard Madden, marks the next chapter in our partnership with the iconic fashion house. The fragrance and campaign embrace the spirit of pushing boundaries as personified through our Dare to Defy concept and celebrates the courageous leap of faith it takes to follow your convictions while acknowledging the vulnerability and courage to defy expectations. We are confident that Calvin Klein Defy, which encapsulates a renewed take on masculinity, self-reflection and defiance, will resonate with modern men across the world, driving further global demand for Calvin Klein fragrances.”

To celebrate the launch of Calvin Klein Defy, a branded tournament will take place on Twitch where consumers will have the opportunity to defiantly battle against top streamers for a chance to win prizes followed by a virtual afterparty.

Calvin Klein Defy is available starting today in select countries and will be available globally on a rolling basis.

About Richard Madden:

Golden Globe winner and Scottish actor Richard Madden is fast becoming one of Hollywood’s most in-demand actors. Upcoming, Madden will be seen in Chloe Zhao’s Eternals in which he portrays the character ‘Ikaris’ opposite Angelina Jolie, Salma Hayek, Kumail Nanjiani, and Gemma Chan. The superhero film based on the Marvel Comics of the same name follows the saga of the Eternals, a race of immortal beings who lived on Earth and shaped its history and civilizations. The film is slated for release by Disney on November 5, 2021. Additionally, he is currently in production on the Russo Brothers’ CITADEL alongside Priyanka Chopra Jonas. The upcoming global thriller multi-series for Amazon Studios will feature interconnected, local-language versions of the story in several other countries.

About Calvin Klein, Inc.

Calvin Klein is a fashion lifestyle brand with bold, progressive ideals and a sensual aesthetic that is recognized worldwide. Our modern and minimalist approach to design, provocative imagery and authentic connection to culture has resonated with customers for over 50 years.

Founded in 1968 by Calvin Klein and his business partner Barry Schwartz, we have built our reputation as a leader in American fashion through the distinct Calvin Klein brand lines and a licensed range of products. We were acquired by PVH Corp. in 2003. For more information, please visit www.calvinklein.com.

About COTY Inc.

Coty is one of the world’s largest beauty companies with an iconic portfolio of brands across fragrance, color cosmetics, and skin and body care. Coty is the global leader in fragrance, and number three in color cosmetics. Coty’s products are sold in over 150 countries around the world. Coty and its brands are committed to a range of social causes as well as seeking to minimize its impact on the environment. For additional information about Coty Inc., please visit www.coty.com.

ADVERTISING CREDITS:

Creative Agency: The Style Council

Still life photographer: Thomas Legrand

EDITORIAL CREDIT: Calvin Klein Defy

TVC:https://youtu.be/cPX33PuC9UA

SOCIAL MEDIA: #ckdefy

BRAND HANDLE: @calvinklein

Calvin Klein, Inc.

Erin Leary, Director Corporate Communications, Calvin Klein, [email protected]

Coty, Inc.

Ariel Dunne, Senior Director, Influencer Marketing, [email protected]

Jason Noda, Senior Manager, Influencer Marketing, [email protected]

KEYWORDS: North America United States Europe South America Central America New York

INDUSTRY KEYWORDS: Cosmetics Men Retail Entertainment Consumer Luxury Celebrity Teens Advertising Communications TV and Radio Specialty Women Fashion

MEDIA:

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Calvin Klein Defy (Photo: Business Wire)
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FDA Approves Dose Escalation Label Update for Puma Biotechnology’s NERLYNX® (neratinib) in HER2-Positive Early Stage and Metastatic Breast Cancer

FDA Approves Dose Escalation Label Update for Puma Biotechnology’s NERLYNX® (neratinib) in HER2-Positive Early Stage and Metastatic Breast Cancer

Dose escalation of NERLYNX therapy demonstrated improved management and prevention of Grade 3 diarrhea

LOS ANGELES–(BUSINESS WIRE)–
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) approved a labeling supplement to the U.S. Prescribing Information for NERLYNX® that incorporates the use of NERLYNX dose escalation as evaluated in the Phase II CONTROL Trial and the new 133 count commercial NERLYNX SKU. The new 133 count SKU, i.e., a bottle containing a four-week supply of 133 tablets, is aligned with the use of NERLYNX dose escalation and designed to better support patient needs.

The CONTROL study was a multicenter, open-label, multi-cohort trial evaluating patients with early stage HER2-positive breast cancer treated with NERLYNX 240 mg daily for up to one year who received loperamide prophylaxis with additional anti-diarrheal treatment as needed (PRN) or NERLYNX dose escalation with loperamide as needed. Patients in the dose escalation cohort received NERLYNX 120 mg daily for Week 1, followed by NERLYNX 160 mg daily for Week 2, followed by NERLYNX 240 mg daily for Week 3 and thereafter for the duration of treatment.

Data from this study showed that dose escalation in the extended adjuvant setting, coupled with PRN Loperamide, led to a greater than 60% reduction in the percentage of patients who experienced Grade 3 diarrhea (40% vs. 13%), a 50% reduction in median cumulative days of Grade 3 diarrhea (5 days vs. 2.5 days) and an approximate 80% reduction in discontinuation rates (17% vs. 3%) when compared to ExteNET, where no dose escalation or antidiarrheal prophylaxis was mandated.

Hope S. Rugo, MD, Professor of Medicine at the University of California San Francisco Comprehensive Cancer Center, said, “The inclusion of dose escalation in the prescribing information is a critical road-map for health care providers and patients as they seek to optimize treatment and reduce therapy-related toxicity in the early breast cancer and metastatic settings.”

Alan H. Auerbach, Chief Executive Officer and President of Puma, said, “We believe that utilizing dose escalation has the potential to improve the overall tolerability of NERLYNX and increase the average length of therapy, with the end result benefiting more patients battling breast cancer.”

About HER2-Positive Breast Cancer

Up to 20% of patients with breast cancer tumors over-express the HER2 protein (HER2-positive disease) and in the ExteNET study, 57% of patients were found to have tumors that were hormone-receptor positive. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer recurring, up to 25% of patients treated with trastuzumab experience recurrence within 10 years, the majority of which are metastatic recurrences.

About Puma Biotechnology

Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc.

Further information about Puma Biotechnology may be found at www.pumabiotechnology.com.

IMPORTANT SAFETY INFORMATION

NERLYNX® (neratinib) tablets, for oral use

INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated:

  • As a single agent, for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.
  • In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer, who have received two or more prior anti-HER2 based regimens in the metastatic setting.

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:

  • Diarrhea: Manage diarrhea through either NERLYNX dose escalation or loperamide prophylaxis. If diarrhea occurs despite dose escalation or loperamide, treat with loperamide, additional antidiarrheals, fluids, and electrolytes as clinically indicated. Withhold NERLYNX in patients experiencing severe and/or persistent diarrhea. Permanently discontinue NERLYNX in patients experiencing Grade 4 diarrhea or Grade ≥ 2 diarrhea that occurs after maximal dose reduction.
  • Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. Withhold NERLYNX in patients experiencing Grade 3 liver abnormalities and permanently discontinue NERLYNX in patients experiencing Grade 4 liver abnormalities.
  • Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

ADVERSE REACTIONS:

The most common adverse reactions (reported in ≥ 5% of patients) were as follows:

  • NERLYNX as a single agent: Diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increased, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased, and urinary tract infection.
  • NERLYNX in combination with capecitabine: Diarrhea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, weight decreased, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms.

To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS:

  • Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors. Separate NERLYNX by at least 3 hours with antacids. Separate NERLYNX by at least 2 hours before or 10 hours after H2-receptor antagonists. Or separate NERLYNX by at least 3 hours with antacids.
  • Strong CYP3A4 inhibitors: Avoid concomitant use.
  • P-gp and moderate CYP3A4 dual inhibitors: Avoid concomitant use.
  • Strong or moderate CYP3A4 inducers: Avoid concomitant use.
  • Certain P-gp substrates: Monitor for adverse reactions of P-gp substrates for which minimal concentration change may lead to serious adverse reactions when used concomitantly with NERLYNX.

USE IN SPECIFIC POPULATIONS:

  • Lactation: Advise women not to breastfeed.

Please see Full Prescribing Information for additional safety information.

To help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance. More information on the Puma Patient Lynx program can be found at www.NERLYNX.com or 1-855-816-5421.

Forward-Looking Statement

This press release contains forward-looking statements, that involve risks and uncertainties that could cause Puma’s actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, any adverse impact on Puma’s business or the global economy and financial markets, generally, from the global COVID-19 pandemic, and the risk factors disclosed in the periodic and current reports filed by Puma with the Securities and Exchange Commission from time to time, including Puma’s Annual Report on Form 10-K for the year ended December 31, 2020. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Puma assumes no obligation to update these forward-looking statements, except as required by law.

Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500

[email protected]

[email protected]

David Schull or Maggie Beller, Russo Partners, +1 212 845 4200

[email protected]

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Research FDA Clinical Trials Biotechnology Health Pharmaceutical Other Science Science Oncology

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